Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

Overview

This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

Full Title of Study: “Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Detailed Description

The main objective of the study is to assess the proportion of successfully treated patients (success rate).

That is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema :

Group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage).

Group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + Cellu M6 for 5 days Group 3: Bandages + Cellu M6 for 5 days

Symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (HAS 2012 ISL International Society of Lymphology, 2013).

Interventions

  • Procedure: intensive decongestive treatment
    • intensive decongestive treatment
  • Device: Cellu M6
    • Use of Cellu M6

Arms, Groups and Cohorts

  • Active Comparator: intensive decongestive treatment (IDT)
    • Patients will receive an intensive decongestive treatment for 5 days
  • Experimental: IDT + Cellu M6
    • Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
  • Active Comparator: Cellu M6 + bandages
    • Patients will receive an bandages + Cellu M6 for 5 days

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
    • Time Frame: 6 months

Secondary Measures

  • Progression of the excessive volume in the arm since hospitalization
    • Time Frame: 6 months
  • assess adverse effects
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL)
  • Patients suffering from Lymphoedema for 6 months or more
  • Patients with a difference between arms >10%
  • Patients who had ever had an axillary node dissection
  • Patients hospitalized for intensive standard treatment.

Exclusion Criteria

  • Primary lymphoedema
  • Venous insufficiency of the upper members
  • severe arterial obstruction
  • obliterating arteritis of the upper limbs
  • Bilateral lymphoedema
  • Breast cancer recurrence
  • Another cancer in treatment
  • Decompensated heart failure
  • Pacemaker
  • acute infection
  • Deep venous thrombosis
  • Skin atrophy of the upper member
  • Bullous dermatosis
  • Acute dermatitis with epidermitis or dermatitis-hypodermitis
  • Infected wound
  • Inflammatory scar or consequence of a recent surgery (<1 month)
  • Presence of osteosynthesis equipment under the skin with an external part in the upper member to treat
  • Hyperalgesia of the shoulder
  • Pregnancy.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Toulouse
  • Collaborator
    • LPG SYSTEMS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julie MALLOIZEL-DELAUNAY, MD, Principal Investigator, University Hospital, Toulouse

References

Lawenda BD, Mondry TE, Johnstone PA. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):8-24. doi: 10.3322/caac.20001. Review.

Kärki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-9. doi: 10.1080/02841860902755251. Review.

Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphat Res Biol. 2009;7(2):101-8. doi: 10.1089/lrb.2009.0006.

Vignes S, Porcher R, Arrault M, Dupuy A. Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Res Treat. 2007 Mar;101(3):285-90. Epub 2006 Jul 7.

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